Catalent Launches ADVASEPT™ Advanced Aseptic Technology
Product News Mar 15, 2014
Catalent Pharma Solutions has announced that it will launch its new ADVASEPT™ technology, for the advanced aseptic filling of injectable drugs, at the forthcoming INTERPHEX exhibition, which takes place from the 18th to the 20th of March at the Javits Center, New York City, NY.
The new platform provides a glass-free, aseptically filled, primary container that reduces or eliminates many concerns associated with traditional glass vials, including the risk of injuries to treatment providers and patients, the potential for glass particulate contamination and accidental breakage in transit and subsequent product wastage.
“This new technology eliminates the risk of glass particulate contamination, significantly reduces the risk of breakages and minimizes container weight through the use of an ultrapure plastic design,” commented Catalent’s Jonathan Arnold, Vice President and General Manager of Advanced Delivery Technologies. “Catalent also brings analytical expertise in areas such as biologic substance testing, extractables and leachables, and stability, and we have scientifically shown comparability of a monoclonal antibody between traditional glass and ADVASEPT vials.”
ADVASEPT vial production leverages proven Quality by Design manufacturing techniques that have optimized the blow-fill-seal manufacturing process. Leveraging this form of advanced aseptic processing, a stopper is inserted during the blow-fill-seal process to create a next generation, glass-free injectable solution, minimizing the risk of contamination by reducing particles, process steps, and human interaction.
Significant reductions in controlled space requirements also drive out the operational and fixed costs of traditional vial filling while decreasing the risk of contamination. Available with safe, easy to open pop-off or twist-off tops, the ADVASEPT stoppered vial is currently produced in 10mL, 50mL and 100 mL sizes.
ADVASEPT vials are manufactured at Catalent’s Woodstock, IL facility, and are highly customizable. Containers can be tailored to meet the unique needs of customers across many markets, such as biologics, pharmaceuticals, generics, and animal health.